Cardiovascular DiseasesNCT01930149
Promoting Cholesterol Screening
A study testing Mailed patient outreach intervention in people with Cardiovascular Diseases and Lipid Testing, run by Northwestern University at 3 sites in United States.
Trial summary
Cholesterol screening is an important prerequisite for cardiovascular disease (CVD) risk assessment. Cholesterol screening is recommended by the United States Preventive Services Task Force (USPSTF). Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Cardiovascular Diseases, Lipid Testing, Primary Prevention of Cardiovascular Disease
- What is being tested?
- Mailed patient outreach intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 3 sitesUnited States
- Study dates
- Dec 2013to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient at participating health center
- At least 1 visit to clinic in the prior 12 months
- No total cholesterol and high-density lipoprotein cholesterol result recorded in the electronic health record in the past 5 years
- No cholesterol screening order placed within the previous 3 months
- Men 35-75 years old, or women 45-75 years old who also have one of the following: hypertension, obesity, or current smoking
Who cannot join
- Previously diagnosed cardiovascular disease, peripheral arterial disease or diabetes mellitus
- Statin on active medication list
- Preferred language other than English or Spanish
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Near North Health Service Corporation
Chicago, Illinois, 60610
Heartland Health Outreach
Chicago, Illinois, 60645
North Country Health Care
Flagstaff, Arizona, 86004
About this study
Official title: Reducing Disparities in Primary Prevention of Cardiovascular Disease: Promoting Cholesterol Screening
Cholesterol screening is an important prerequisite for cardiovascular disease (CVD) risk assessment. Cholesterol screening is recommended by the United States Preventive Services Task Force (USPSTF). Since reminder systems have been shown to modestly improve the rates of preventive services, including in safety net settings, we will implement patient-directed reminders to health center patients who meet our eligibility criteria.
The aim of this study is to determine if a mailed outreach message and facilitated ordering of screening lipid tests increases cholesterol screening test completion within 3 months among federally qualified community health center patients who are eligible for screening compared to usual care.
- Being tested
- Mailed patient outreach intervention
- Keywords
- Cholesterol screening, High cholesterol, Cardiovascular disease, Statin treatment
- Medical subject headings
- Cardiovascular Diseases, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mailed patient outreach interventionBehavioural
This study's intervention is a mailed outreach letter from the health center that encourages cholesterol testing and describes the steps necessary to obtain the test at the patient's care site. Clinic staff will facilitate the ordering of tests for patients who may not have an office visit.
| Study group | Role | What they receive |
|---|---|---|
| Mailed patient outreach intervention | Experimental | Participants randomized to this arm will receive mailed letter from health center that encourages cholesterol testing and describes the steps necessary to obtain the test at the patient's care site. Clinic staff will facilitate the ordering of tests for patients who may not have an office visit. Receives: Behavioral: Mailed patient outreach intervention |
| Usual Care Control Group | No intervention | Participants randomized to this arm will receive usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of total cholesterol and HDL cholesterol test or full lipid panel
Primary outcome will be completion of total cholesterol and HDL cholesterol test or a full lipid panel recorded within GE Centricity electronic health record at the patient's clinical site.
Measured: within 3 months of outreach
Secondary outcomes (1)
Statin prescription
Secondary outcome is prescription of a statin as assessed by automated electronic queries of electronic health record.
Measured: within 3 months of outreach
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2013 (estimated)
- Study startDec 2013
- Primary completionMar 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 480 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Stephen Persell, Northwestern University
- Investigators
- Stephen D Persell, MD, MPH, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01930149
- Sponsor's protocol ID
- 1PO1HS021141-01-Project 2B
- Other IDs
- 1P01HS021141-01
- Status last verified
- Sep 2014
- First submitted
- 23 Aug 2013
- Last updated
- 29 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Disparities in Primary Prevention of Cardiovascular Disease: Promoting Cholesterol Screening
- ClinicalTrials.gov ID
- NCT01930149
- Acronym / sponsor ID
- 1PO1HS021141-01-Project 2B
- Keywords
- Cholesterol screening, High cholesterol, Cardiovascular disease, Statin treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Dec 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 28 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cholesterol screening is an important prerequisite for cardiovascular disease (CVD) risk assessment. Cholesterol screening is recommended by the United States Preventive Services Task Force (USPSTF). Since reminder systems have been shown to modestly improve the rates of preventive services, including in safety net settings, we will implement patient-directed reminders to health center patients who meet our eligibility criteria.
The aim of this study is to determine if a mailed outreach message and facilitated ordering of screening lipid tests increases cholesterol screening test completion within 3 months among federally qualified community health center patients who are eligible for screening compared to usual care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mailed patient outreach intervention | Experimental | Behavioral: Mailed patient outreach interventionParticipants randomized to this arm will receive mailed letter from health center that encourages cholesterol testing and describes the steps necessary to obtain the test at the patient's care site. Clinic staff will facilitate the ordering of tests for patients who may not have an office visit. |
| Usual Care Control Group | No intervention | –Participants randomized to this arm will receive usual care. |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient at participating health center
- At least 1 visit to clinic in the prior 12 months
- No total cholesterol and high-density lipoprotein cholesterol result recorded in the electronic health record in the past 5 years
- No cholesterol screening order placed within the previous 3 months
- Men 35-75 years old, or women 45-75 years old who also have one of the following: hypertension, obesity, or current smoking
Key exclusion criteria (3 listed)
- Previously diagnosed cardiovascular disease, peripheral arterial disease or diabetes mellitus
- Statin on active medication list
- Preferred language other than English or Spanish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mailed patient outreach interventionThis study's intervention is a mailed outreach letter from the health center that encourages cholesterol testing and describes the steps necessary to obtain the test at the patient's care site. Clinic staff will facilitate the ordering of tests for patients who may not have an office visit. | Behavioural | Mailed patient outreach intervention |
Primary outcome
Completion of total cholesterol and HDL cholesterol test or full lipid panel
Time frame: within 3 months of outreach
Primary outcome will be completion of total cholesterol and HDL cholesterol test or a full lipid panel recorded within GE Centricity electronic health record at the patient's clinical site.
1 secondary outcome
Statin prescription
Time frame: within 3 months of outreach
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen D Persell, MD, MPH principal investigator
Northwestern University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mailed patient outreach intervention in people with Cardiovascular Diseases and Lipid Testing, run by Northwestern University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion of total cholesterol and HDL cholesterol test or full lipid panel (time frame: within 3 months of outreach). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2014.